Testimonies to your Success
On time delivery of potent and controlled products OSD Facility
Designed, constructed, commissioned and validated an Oral Solid Dosage Manufacturing Facility. Client launched the product on time allowing the company to seize a significant amount of market-share before the competition was able to enter the market.
Cost Effective Level 4 Serialization Solution
Installed level 4/5 US DCSCA compliant track and trace system which required the re-design of secondary packaging area. Ultra Tab invested 20% below industry average and the delivery of the system was 2 months ahead of schedule.
30% Manufacturing Capacity Increase
Successfully supported a 30% manufacturing increase in capacity and commensurate market-share increase for a life-saving medical device.
Increased throughput and compliance position Designed, Purchased, Commissioned, Qualified, and Started-up two high speed, state of the art tablet packaging lines. Project completed on time and on budget. Throughput increased by over 40%. Customer complaints on tablet counts reduced by 90%.
- 8-Head Cremer Filling Technology
- Designed for controlled substances and potent compounds
503B Pharmacy sterile filling and OSD suite Programming Programmed the design, specification, purchase, installation, commissioning and qualification of a new ~$30M 503B Pharmacy sterile filling and OSD suite with flexible packaging line systems.
Our Value-Added Impact
A large fortune 500 company recognized that global serialization regulations were being promulgated by various Boards of Health and that it was only a matter of time before the major US and European markets promulgated their own regulations to address pharmaceutical supply chain safety and security.
Having identified the impending issue to the company’s senior management, Bob was tapped to lead the Executive Steering Team, develop the strategy, establish budgets and publish timelines for
An Executive Steering Team was immediately established, as well as working and operational team for the local implementation of serialization across all business segments. Further, a specialized team was developed in order to manage the extensive 3 rd party manufacturing and packaging network. The Executive Steering Team and the operational teams included representatives from the company’s executive management team, operations, marketing, sales, quality, technical operation (engineering and technical services), government affairs, IT, finance and human resources.
A strategic plan was developed and rapidly approved by the organization which aligned the organization around the approach and management of principle compliance pathways. Further, it addressed strategic implementation of serialization in future markets.
Based on the approval of the strategic plan, an operational plan was developed that identified all of the assets internally and externally to the network, requirements for compliance that were needed and order of magnitude costs and timelines for schedule attainment. From this information, the serialization program was funded and then annually adjusted to accommodate updated guidance and new technology.
The company is well positioned for compliance with US, European and Rest of World serialization compliance and is beginning to explore alternative business benefits of serialization for managing its supply chain as well as validating and operationalizing a flexible and elegant infrastructure for managing the physical compliance (labeling, high speed printing, variable data management, etc.) requirements while the corporation begins to focus on its upper level data management and computer systems.